Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
Foreign body sensation in the throat; Headache; Dizziness; Tachycardia; Oropharyngeal pain; Hypotension (90/60); This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18672-13 . A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Dec2021 (Lot number: 330208D, Expiration Date: 01Feb2022) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOREIGN BODY IN THROAT (medically significant) with onset 09Dec2021, outcome "recovered", described as "Foreign body sensation in the throat"; HEADACHE (medically significant) with onset 09Dec2021, outcome "recovered", described as "Headache"; DIZZINESS (medically significant) with onset 09Dec2021, outcome "recovered", described as "Dizziness"; TACHYCARDIA (medically significant) with onset 09Dec2021, outcome "recovered", described as "Tachycardia"; OROPHARYNGEAL PAIN (medically significant) with onset 09Dec2021, outcome "recovered", described as "Oropharyngeal pain"; HYPOTENSION (medically significant) with onset 09Dec2021, outcome "recovered", described as "Hypotension (90/60)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (09Dec2021) (90/60). Therapeutic measures were taken as a result of foreign body in throat, headache, dizziness, tachycardia, oropharyngeal pain, hypotension. Clinical course: The patient was received in the extended consultation service 10 minutes after vaccination, where she presented with tachycardia, headache, on assessment she was found hypertension (90/60), and oropharyngeal pain with a sensation of a foreign body in the throat her symptoms were treated and she was discharged with total improvement in her signs and symptoms. Treatment administered: Diphenhydramine 20mg intravenous single dose. No follow-up attempts are possible. No further information is expected.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | 330208D | OT | RA |
| RECVDATE: | 03-29-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20211209; Test Name: blood pressure; Result Unstructured Data: Test Result:(90/60) |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | MXPFIZER INC202200433281 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-28-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.